Media question 6 biological cell immunotherapy: the United States has failed | Wei Zexi | cell therapy _ news
From synovial Sarcoma detected, until his death at the age of 21 years old young man Wei Zexi spent two years. Although unwilling to believe that a young life gone after all. And his "knowledge" on the message, let hospitals of armed police corps in Beijing biological cell immunotherapy "up front", become the object of inquiry, Beijing News reporter interviews prove, trying to unlock the mystery surrounding the therapy.
Questions 1 what kind of disease is how to treat synovial Sarcoma?
There are indications, Wei Zexi "synovial Sarcoma" is derived from the joint, the synovium and synovial tendon sheath of soft tissue cancer.
It is retroperitoneal tumors of soft tissue tumor hospital and Director of the center of Beijing University Hao Chunyi introduced, includes synovial Sarcoma, "Sarcoma" and we used to say "cancer" are two types of malignant tumors of different origin. Among them, occur in is called a sarcoma of soft tissues, such as fat Sarcoma, Leiomyosarcoma, fibrosarcoma, and so on. And cancer incidence, treatment and therapeutic effects are not the same.
Hao Chunyi introduction synovial sarcoma of predilection include limbs, trunk and retroperitoneal.
He said synovial Sarcoma in clinical practice is not common, there is no precise incidence statistics. Location of the retroperitoneal soft tissue sarcoma incidence in one out of 10,000, is a rare disease.
Hao Chunyi introduction, including retroperitoneal soft tissue sarcoma, synovial Sarcoma treatment, treatment for doctors and hospitals, technology, experience, treatment and treatment modalities, and the team has very high demands. Due to the effects of too many factors at different doctors, hospitals, treatment results are very different. This situation not only in the domestic, American and European countries as well. Therefore, suggest patients to specialty hospitals and treatment centres.
He said that one of the characteristics of retroperitoneal soft tissue sarcoma that most existing chemotherapy, radiotherapy and other means are less sensitive, surgery is the only potential chance of cure, treatments to patients.
He pointed out that the treatment of retroperitoneal soft tissue sarcoma, even within professional has not reached a consensus. This tumor is mainly rely on surgery, and some complementary treatments including chemotherapy, radiotherapy, etc. For Immune therapy, soft tissue sarcomas are not very mature and effective means.
Question 2 How immune therapy treatment?
Armed police Beijing Corps second hospital provides of "biological immune therapy", that is in domestic was widely using of "DC-CIK biological immune therapy", its principle for first extraction patients of DC cell, in body outside will its induced mature, while extraction patients of lymphocytes, in body outside activated became CIK cell, will DC and CIK two species cell common training for tumor antigen presenting, activated tumor Antigen corresponding of lymphocytes, again put they lost to patients body.
Reporter by Baidu search to enter "Ke St hospital, Shanghai official site" on this page introduces "immune cell therapy" concrete therapeutic steps. The hospital's Web site describes, in the course of treatment, the patient cells extracted on the first day, on the seventh day of its clinical injection, back after 7 days, patients start to the second cell in the treatment process, just 2 treatments per month, 3-6 month for a course of treatment.
Yesterday, the reporter by Baidu search into the "Zhongshan Hospital of Jinan" Web interface, to patients with hepatitis b Yang identity Advisory page pops up a "Wang", doctor Wang at first declined to DC cell to immune therapy of specific circumstances, at a press conference, under repeated questioning, Wang said, a course of treatment cost about one thousand or two thousand Yuan.
"Zhongshan Hospital of Jilin" website introduces this therapy for hepatitis b Yang a course cost thousands of Yuan, in particular costs depending on the circumstances, ranging from hundreds of thousands of Yuan.
Reporters found in the Baidu search, on December 25, 2015, named "Wen Hongze oncologists" user replies to netizens asked, said cell immunotherapy for cancer costs a course around 30,000 yuan, different regions, different hospitals for treatment costs may vary. Basic information on the Wen Hongze doctor claiming to be a physician hospitals of armed police corps in Beijing tumor biology Center, residence, Xicheng District, Beijing.
Question 3 "treatment technology" is ripe?
Wei Zexi second in Beijing, armed police corps hospital is using a "DC treatment technology", caused controversy in recent days. Hao Chunyi explained that immunotherapy with DC technology itself is actually very sophisticated technology, the key is how to apply.
According to Hao Chunyi, the "immunotherapy" principle is to mobilize the body's resistance, fighting against tumor cells, instead of chemotherapy, radiotherapy and other "killing". In theory, this is a development direction for cancer treatment and current research in the field of cancer treatment.
However, Hao Chunyi pointed out that immunotherapy for the treatment of certain diseases better, such as renal cell carcinoma, melanoma, lymphoma, are carried out in many hospitals. But for many tumors, immunotherapy is still at the research stage, and with no apparent effect. For Wei Zexi synovial Sarcoma cancer, immunotherapy is not ripe for treatment.
According to data provided by some researchers, after the use of DC-CIK therapy, some patients ' long-term survival rate has improved. In a study sponsored by the Tianjin tumor hospital, DC-CIK in patients with non-small cell lung cancer's one-year survival rate of nearly 20%. But until now, there is no direct evidence that this therapy can cure cancer, played a decisive role.
According to app, public "intellectuals" reports, CIK/DC-CIK therapy had been in the United States after years of study, but its clinical trial in the United States almost all failed, the vast majority of treatments based on this method are not approved by the listing. At present, the United States has few DC-CIK therapy in clinical trials.
Question 4 how universal is the biologic immune therapy?
Yesterday, the Beijing News reporter found that "immune cell therapy" at many hospitals as a means of therapy. In addition, some hospitals also use this therapy for liver diseases, sexually transmitted diseases, and so on.
Reporters at the Baidu search "DC immune cell therapy" and other keywords and found that many hospitals on its website, and released "DC cell to immune therapy", "DC-CIK cell immunotherapy", "CIK immune therapy", "CLS cell immunotherapy" treatment.
According to media reports, Dr He Ting, Tsinghua University accepted "intellectual" was introduced in an interview, DC-CIK treatment in many hospitals have been applied to a variety of different stages of cancer treatment. Probably include lung cancer, liver cancer, stomach cancer, colon cancer, kidney cancer, acute and chronic leukemias, lymphoma, nasopharyngeal tumor, malignant melanoma, breast cancer, cervical cancer, prostate cancer, tongue cancer, thyroid cancer, and so on.
Beijing News reporter read shows that in recent years, immune cell therapy in domestic provinces and cities, large hospitals have used. In September 2011, the Tianjin Municipal tumor hospital, media reported results of a study, patients with advanced lung cancer, gastrointestinal cancer, renal cell carcinoma and secondary biological treatment the average survival period can be extended by 1 to 3 times, overall treatment efficiency can be increased by approximately 15%.
Last year, the Hubei channel Xinhua report shows that Wuhan Tongji hospital successfully used cellular immunotherapy: a case of leukemia, for treatment of a patient with relapsed refractory leukemia, with the most sensitive molecular detection technology has been completely unable to find trace of leukemia cells.
Question 5 the introduction of new technology of the process?
"Wei Zexi events" in the hospitals of armed police corps in Beijing says its technology is introduced by Stanford University. So, at the national level, introduction of new technologies in hospitals through what process?
Beijing news reporters yesterday in the industry, hospitals for the introduction of major new technologies must adopt the relevant approval and filing procedures. Among them, the clinical trials and the result is a "hard"; in addition, hospitals are required to submit includes the feasibility study report and other materials, for auditing by professional bodies. Must provide specified in the report, is the application of this technology at home and abroad.
Reporters learned that, according to the Ministry of health-related approach, immune cell therapy techniques have been considered "involves significant ethical issues, safety and effectiveness of standard clinical trials are needed to further validate the medical technology", but which are not included.
Provisions relating to the introduction of medical technology, reporters found that in 2009, according to the Ministry of health published the clinical management of application for medical technology, medical technology is divided into three classes, the Ministry of health is responsible for the clinical application of the third class medical management.
The same year, the original Ministry of health published the first catalogue of class III medical technology allows clinical application, "autoimmune cells (t-cells, NK cells) treatment technology" to be included. To validate a clinical application of health administrative departments are the Ministry of health.
However, last July, according to the decision on the removal of administrative approval items, State Health Planning Commission issued a notice that, cancel approval class III medical technology clinical practice admittance.
In the notice, State Health Planning Commission said, prohibit clinical application in the medical safety and effectiveness of some of the major issues in medical technology, which "immune cell therapy," not one of them.
Question 6 biological immunotherapy is taken in charge?
At home, the cancer immuno-cell therapy has been declared as in addition to surgery, chemotherapy, radiotherapy fourth class treatment technology. As early as in 1992, the people's Hospital of Peking University started the early immune cell therapy. But it was not until 2003, when the State food and Drug Administration was issuing the human cell therapy research and quality control techniques guiding principles, products included in the scope of regulation of immune cells for the first time. After 2005, accompanied by a personal earthquake, food and Drug Administration is no longer accepting approval of biologic therapy until the end of this, immunotherapy was transferred to the jurisdiction of the health sector.
In the four years from 2005 to 2009, immunotherapy with Ministry of health not to any actual management practices.
In accordance with the relevant provisions of management measures of medical technology clinical practice, health planning Commission prior to the ratification of this therapy organized clinical trials and ethics review. In 2014, the southern weekend reported, people in the industry said, Wei JI Wei has never organized such testing or review, cellular immunotherapy for class III medical technologies that allow clinical application.
In this regard, the scientists have wanted to come up with a reasonable solution. In 2009, the Academician Zeng Yixin combined cancer hospital affiliated to Sun Yat-sen University, Tianjin tumor hospital, Beijing 302 hospital and Chinese University of science and technology four units from four to start the research and formulation of standard of cellular immune therapy. This research project in 2013, finished and submitted to health planning, but is still below.
By May 2015, a paper order the cancellation of a third class medical technology approvals, which have not found safety and efficacy of therapies and complete walk in the grey area.
Beijing News reporter Wen Ru Liu Xu intern Dai Xuan
Responsible editor: Ni Zi Jiang
Article keywords:Wei Zexi biological cell therapies
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媒体6问生物细胞免疫疗法:在美国已宣告失败|魏则西事件|生物细胞疗法_新闻资讯
从被检出滑膜肉瘤，到去世，年仅21岁的小伙子魏则西用了两年时间。尽管不愿相信，一个年轻的生命终究还是走了。而他的一段“知乎”上的留言，让武警北京总队第二医院的生物细胞免疫疗法“走上台前”，成为被追问的对象，新京报记者为此多方采访求证，试图解开围绕疗法的谜团。
疑问1 滑膜肉瘤是种什么病怎么治？
有资料显示，魏则西所患的“滑膜肉瘤”是源于关节、滑膜及腱鞘滑膜的软组织的恶性肿瘤。
据北大肿瘤医院软组织和腹膜后肿瘤中心主任郝纯毅介绍，包含滑膜肉瘤在内的“肉瘤”和我们常说的“癌”属于不同起源的两大类型恶性肿瘤。其中，发生于软组织的叫做肉瘤，比如脂肪肉瘤、平滑肌肉瘤、纤维肉瘤等。它和癌的发病率、治疗方式和治疗效果等都不尽相同。
郝纯毅介绍，滑膜肉瘤的好发部位包括肢体、躯干、腹膜后等。
他表示，滑膜肉瘤在临床上并不常见，目前没有精准的发病率统计。位置在腹膜后的软组织肉瘤，发病率在十万分之一以下，属于罕见病。
郝纯毅介绍，像包括滑膜肉瘤在内的腹膜后软组织肉瘤的治疗，对医生和医院的治疗观念、技术、经验、治疗团队乃至治疗模式等方面都有很高要求。由于受影响 因素太多，在不同医生、医院治疗的效果有很大差别。这种情形不仅在国内，在欧美发达国家也是如此。因此，建议患者一定要去专业医院和治疗中心治疗。
他说，腹膜后软组织肉瘤的一大特点，就是大多数对现有化疗、放疗等手段均不太敏感，手术是唯一能给病人带来潜在治愈机会的治疗手段。
他指出，腹膜后软组织肉瘤的治疗，即使在专业人士内部也未达成共识。这种肿瘤目前主要是依靠手术，还有一些辅助治疗手段包括化疗、放疗等。对于免疫治疗，软组织肉瘤尚没有很成熟有效的手段。
疑问2 生物免疫疗法怎么治疗？
武警北京总队第二医院提供的“生物免疫疗法”，即是在国内被广泛使用的“DC-CIK生物免疫疗法”，其原理为首先提取患者的DC细胞，在体外将其诱导成熟，同时提取患者的淋巴细胞，在体外激活成为CIK细胞，将DC和CIK两种细胞共同培养进行肿瘤抗原呈递，激活肿瘤抗原相应的淋巴细胞，再把它们输给病人体内。
记者通过百度搜索进入“上海新科医院肝病科官方网站”，该页面上详细介绍了“免疫细胞疗法”的具体治疗步骤。该医院网页介 绍，在治疗过程中，第一天对患者进行细胞提取，第七天对其进行临床注射，在回输7天后，患者开始第二次的细胞治疗过程，每月只需治疗2次，3-6个月为一 个疗程。
昨天，记者通过百度搜索进入“济南中山医院”网页界面，以乙肝大三阳患者身份咨询其页面弹出的一位“王医生”，王医生一开始不愿透露DC细胞生物免疫疗法的具体情况，在记者再三追问下，王医生表示，治疗一疗程价格在一两千元左右。
“吉林中山医院”的相关网页则介绍，此疗法治疗乙肝大三阳一个疗程的费用在千元以内，具体费用根据不同情况，从几百到几千元不等。
记者在百度知道中搜索发现，2015年12月25日，一位名为“温洪泽肿瘤医生”的用户回复网友询问表示，细胞生物免疫疗法治疗癌症的费用，一个疗程在 3万元左右，不同地区、不同医院治疗费用可能有所不同。这位温洪泽医生的基本资料中自称是武警北京总队第二医院肿瘤生物中心主任医师，居住地为北京市西城区。
疑问3 “免疫治疗技术”是否成熟？
魏则西在武警北京总队第二医院使用的是“DC免疫治疗技术”，近日引发争议。郝纯毅解释，实际上DC免疫治疗技术本身是很成熟的技术，关键是如何应用。
据郝纯毅介绍，“免疫治疗”的原理是调动患者自身抵抗力、战斗力抵御肿瘤细胞，而非像化疗、放疗等的“直接杀伤”。在理论上来讲，这是肿瘤治疗的一个发展方向，也是当前肿瘤治疗学领域中的研究热点之一。
不过，郝纯毅指出，免疫治疗对于某些病种的治疗效果比较好，像肾癌、黑色素瘤、淋巴瘤等，在很多医院均有开展。但对于很多肿瘤而言，免疫治疗目前还处于研究阶段，并没有取得明显效果。对于魏则西所患的滑膜肉瘤，使用免疫治疗并不是成熟的治疗方法。
国内一些研究者提供的数据显示，使用DC-CIK疗法后，一些病人的远期生存率有所提升。在一项天津肿瘤医院发起的研究中，DC-CIK治疗使非小细胞肺癌患者的一年生存率提高近20个百分点。但直到目前，尚未有直接证据证明，这一疗法能在根治癌症上起到决定性作用。
据微信公众号“知识分子”报道，CIK或DC-CIK疗法此前已在美国经历多年研究，但其相关临床试验在美国基本全部宣告失败，绝大多数基于该方法的治疗技术均未得到上市批准。目前，美国已鲜有DC-CIK疗法的临床试验。
疑问4 生物免疫疗法有多普及？
昨天，新京报记者调查发现，“免疫细胞疗法”在国内许多大医院作为治疗肿瘤的手段开展。另外，还有一些医院用此疗法治疗肝病、性病等。
记者在百度上搜索“DC免疫细胞疗法”等关键字，发现多所医院在其网页上，放出“DC细胞生物免疫疗法”、“DC-CIK生物细胞免疫疗法”、“CIK细胞免疫疗法”、“CLS生物细胞免疫疗法”等治疗手段。
据媒体报道，清华大学博士何霆接受“知识分子”专访时曾介绍，DC-CIK治疗在我国很多医院已被应用于多种癌症不同阶段的治疗。大概包括肺癌、肝癌、胃癌、肠癌、肾癌、急慢性白血病、淋巴瘤、恶性黑色素瘤、鼻咽瘤、乳腺癌、宫颈癌、前列腺癌、舌癌、甲状腺癌等。
新京报记者查阅发现，近年来，免疫细胞疗法在国内各省市多家大医院有使用。2011年9月，有媒体报道天津市肿瘤医院一项研究结果，晚期肺癌、消化道肿瘤、肾癌患者，辅助生物治疗平均生存期可延长1到3倍，治疗总体有效率可提高约15%。
去年，新华网湖北频道一则报道显示，武汉同济医院成功运用细胞免疫疗法治疗一例白血病，接受治疗的一名复发难治白血病患者，用目前最敏感的分子检测技术已完全找不到白血病细胞踪迹。
疑问5 医院引进新技术有何流程？
“魏则西事件”中，武警北京总队第二医院曾称其技术系由斯坦福大学引入。那么，在国内，医院引进新技术需经过怎样的流程？
有业内人士昨天对新京报记者表示，医院对于一些重大新技术的引进，须实行相关审批、备案等程序。其中，临床试验研究和效果算是一个“硬指标”；另外，医院还需递交包含可行性研究报告等材料，供专业机构审核。报告中需具明的一点，便是这项技术在国内外的应用情况。
记者获悉，根据原卫生部相关办法，免疫细胞治疗技术曾被认为是“涉及重大伦理问题，安全性、有效性尚需经规范的临床试验研究进一步验证的医疗技术”，不过不在禁止之列。
关于医疗技术引进的相关规定，记者查询发现，2009年，根据原卫生部公布的《医疗技术临床应用管理办法》，医疗技术被分为三类，原卫生部负责第三类医疗技术的临床应用管理工作。
同年，原卫生部公布《首批允许临床应用的第三类医疗技术目录》中，“自体免疫细胞（T细胞、NK细胞）治疗技术”被纳入其中。负责审定技术临床应用的卫生行政部门是原卫生部。
不过，去年7月，根据国务院《关于取消非行政许可审批事项的决定》，国家卫计委下发通知表示，取消第三类医疗技术临床应用准入审批。
在通知中，国家卫计委还表示，禁止医疗机构临床应用安全性、有效性存在重大问题的一些医疗技术，其中“免疫细胞治疗技术”不在其列。
疑问6 生物免疫疗法是否接受监管？
在国内，癌症免疫细胞疗法曾被宣称为除手术、化疗、放疗外的第四类治疗技术。早在1992年，北京大学人民医院等就开始了早期免疫细胞治疗。但直到 2003年，当时的国家食品药品监督管理局才发布《人体细胞治疗研究和制剂质量控制技术指导原则》，首次将免疫细胞制品列入监管范围。在2005年后，伴随着人事地震，食药监局也不再受理生物疗法的审批，直到这一年底，免疫治疗的管辖权转到了卫生部门。
可在2005年到2009年四年间，卫生部没对免疫治疗出台任何实际管理办法。
按照《医疗技术临床应用管理办法》相关规定，卫计委需在批准这一疗法之前组织临床试验和伦理审查。在2014年南方周末的报道中，有业内人士曾表示，卫计委从未组织过此类试验或审查，就将细胞免疫疗法归为允许开展临床应用的第三类医疗技术。
对此，科学家们也曾想过拿出合理的解决方案。2009年，曾益新院士联合中山大学附属肿瘤医院、天津肿瘤医院、北京302医院和中国科技大学四家单位，从四个环节开展了细胞免疫疗法的标准研究和制定。这一研究项目在2013年结题并提交给卫计委，但至今未有下文。
而到了2015年5月，一纸命令取消了第三类医疗技术的审批工作，这项始终没有认定安全性和有效性的疗法，就此彻底游走于灰色地带。
新京报记者 温薷 刘旭 实习生 戴轩
责任编辑：倪子牮
文章关键词： 魏则西事件 生物细胞疗法
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